Regulated Clinical Studies

Would you want to stay on top of the ever-changing regulatory landscape?

It may be overwhelming to keep up with the various laws and guidelines that govern your industry. At Innvocept Global Solutions, we offer comprehensive regulatory strategy support to help you navigate the complex world of compliance. Our team of experts has years of experience in the industry and is well-versed in the latest regulations and requirements.

Play a pivotal role in developing & executing the regulatory strategy based on study requirements.

Create a structured regulatory dossier compilation & facilitate online submission.

Continuously monitor and understand the regulatory environment based on current guidelines, precedents, and influence of emerging policy issues.

What we offer

Regulatory Strategy Support

We provide support in the creation of a robust regulatory strategy, assistance in online regulatory dossier compilation & submission, & representation on behalf of the sponsor.

We have a deep understanding of the regulatory environment and can provide you with the best strategic guidance to ensure compliance.

Clinical Operations and Project Management

Innvocept provides value-added solutions throughout the phases of project planning, initiation, execution, monitoring, and closure.

The right strategy in site feasibility, study planning, and execution across all phases. You avoid project delays and enable quality compliance with Innvocept.

Data management

We offer both electronic data capture (EDC) and paper-based data management options, data management plans tailored to each customer study's specific needs, and customized reports at timely and periodical intervals.

Helps meet desired business objectives in a cost-efficient manner and offers a holistic view of the study.

Biostatistics solutions from inception

We provide CDISC standards with the capability of sample sizing; study design; protocol writing; randomization; statistical analysis plan; SAS programming; table production for study reports and other vital regulatory submissions; data mining.

We have a wide range of services that can cater to your every need.

Medical & Scientific Writing

We have experienced writers in clinical and regulatory writing who can support all stages of drug development, several therapeutic areas, and product types, with thorough knowledge of regulatory, clinical, and scientific contents flawlessly integrated with technical and quality control proficiencies.

Our services include protocol development & finalization, informed consent forms, clinical study reports, Investigator brochures, patient materials, regulatory documents.

Regulated Clinical Studies